Science & Sensibility

I am confused. I thought this website was about informed choice. Are doctors giving terbutaline to patients without delineating the risks? If i am willing to take on some small increased cardiac risk to increase my child’s chance of survival, why do you want to take that choice away from me?

@S From my experience and many other women’s stories … I would say, no, doctors are not forthcoming with the risks. Cytotec, for example, has for a while carried the FDA warning that it should not be used for labor induction because of increased risk of uterine rupture … and yet, it is still routinely used without any warning.

@ S and Leah: I would add, risks of Terbutaline discussed or not, it truly is not a reasonable (long term) solution for preventing preterm birth. Yes, this blog is all about providing information with which women can make informed choices–and with which maternity care professionals can provide that information. And so, in line with that purpose, this post reminds us that Terbutaline, once used fairly frequently for long-term prevention of pre-term birth is neither a safe nor effective long term prevention method.

I followed the link you provided and read through the FDA safety communication. Down a ways it says, “There are certain obstetrical conditions where the healthcare professional may decide that the benefit of terbutaline injection for an individual patient in a hospital setting clearly outweighs the risk.”

This certainly doesn’t sound like a ban against the use of terbutaline for pre-term labor to me.

Hello All,
Thanks for the robust discussion on Terbutaline. I am going to try to address your concerns in the order received.

S: This website is absolutely about informed choice. The problem with Terbutaline is THAT IT WAS NEVER APPROVED BY THE FDA for the treatment of preterm labor! It is a medication originally indicated for the treatment of acute bronchospasm, i.e. acute airway narrowing such as occurs in an asthma attack. Somewhere along the line a woman had preterm labor and was given terbutaline and her preterm labor stopped. This is what started the “Terbutaline is effective against preterm labor” story. However, once terbutaline was clinically tested, no study has been able to show terbutaline has any effect whatsoever on preterm labor. What researchers did find is that terbutaline has SERIOUS cardiac complications, such as tachyarrhythmias and cardiac arrests (heart stopping and/or death) and these complications are not “small risks” as you stated. Many Physicians are not informing patients that Terbutaline is not indicated for the treatment of preterm labor, that is has not been shown to be effective against preterm labor and that it has these serious cardiac risks. Without this knowledge, a patient is not adequately “informed” and should not be signing consents to use this medication.

Medical professionals take an oath upon graduation “To first do no harm.” In the case of Terbutaline, using it to try to prevent preterm labor when it has been shown to be ineffective AND harmful is in direct violation of this oath. Since it is not indicated or approved for this use by the FDA, it’s use is also unethical.

So no matter what you as a patient may want or how much you wish to exert your freedom of choice, medically, ethically, scientifically and now to an extent legally, it is not okay for physicians to prescribe Terbutaline for the prevention of preterm labor and to do so now exposes them to nearly indefensible liability. This isn’t about freedom on choice. It’s about doing what is effective and safe for a patient’s health.

Leah, I think I covered your statement about informed consent here. But I wholeheartedly agree with you.

Sarah, you are correct. The title of this article should read, “FDA “Warns” Against the use of Terbutaline to Treat Preterm Labor” Thanks for catching that.

While the FDA states that “when a medical professional deems it appropriate to use Terbutaline in the short term and in the hospital, for the treatment of preterm labor”, this new warning and these types of discussions will certainly curb terbutaline use for many obstetricians. Again, the potential risks are just too great.

I think this is easy for you to say from the outside, but from the inside I can tell you that terb certainly stops contractions cold, and having used it hundreds of times I’ve never seen a serious complication. Every OB who ever used it will say the same thing. The difficult thing for OBs to believe is that a drug that clearly stops contractions doesn’t prolong pregnancy. But one can say the same thing about most tocolytic agents.

I realize that the data doesn’t support it in prospective studies, and no longer use it in my practice for that reason.

I think that to some extent terb has been tangled up with home uterine activity monitoring, another intervention of dubious benefit.

@Nicholas Fogelson, MD
As an asthmatic pregnant mother let me assure you the risks are not being shared witht the patient. On 2/19/2011 i went into preterm labor. Just that morning i had read the fda reccomendation on terbutaline.
Upon admission to L&D a doctoer i never was once while there prescribed terbutaline to halt my contractions. I expressed my alarm with the nurse and explained to her i had just used my albuterol inhaler ( which also causes increased heart rate) and asked in combinng the 22 meds was dangeroous esp given the fda reccomendation.
Nurse then call absent DR again. tries to push terbutaline aqgain i had to tell her to get the dr to come tell me risk/ benefit and efficacy of the medication befoe I would consent. Suddenly terbutaline was off the table.Never saw Dr. never Had ANY healthcare provider explain risks. If i hadn’t been a somewhat informed consumer i could have been place simultaneously on contraindacateed meds.
And a med that has no overall efficacy in it’s proposed goal.

Kendra,
Wow! Bravo for standing firm and not submitting to ANYTHING without being fully informed. More consumers have to be aware of their medical histories, what current medications they are taking and potential side effects so they can share the information with their attending physicians. I’m surprised that the OB did not come and explain his/her plan with you and the risks/benefits of Terbutaline. That could have had a really unpleasant outcome for which they would have been completely liable. Glad you are okay.

I have some concerns with the (lack of) facts in this article. One, the FDA has not banned terbutaline as the headline suggests, but has warned against prolonged use. Two, short-term use is all that has been advocated by ACOG and other societies for a number of years, specifically, sufficiently short-term use to allow for the administration of lifesaving and disability-preventing corticosteroids (promoting lung maturity and decreasing the risk of intraventricular hemorrhage – ie brain bleeding – in very preterm infants that increases the risk of cerebral palsy). There IS good evidence of delay of delivery in this setting WITHOUT increased risks for women taking this medication. Finally, a call for a complete halt to terbutaline use, and a naive indictment of physicians and the FDA, will both INCREASE cerebral palsy in infants WITHOUT improving terbutaline’s already-proven safety for short-term, low-dose use. Your tone is both rude and un-called for. Ms. Turner-Lee, you are welcome to spend 8-12 years in graduate and post-graduate education so that you can become a researcher and find better treatment for preterm labour, since you seem to suggest it is such a straightforward endeavour. There are already many brilliant minds working on this very dilemma, and your condescension is disrespectful of their unrelenting efforts.
Since the start of my practice life we have lost our supply of terbutaline (and its cousin ritodrine) in Canada, and without an adequate replacement are left using nifedipine (a calcium-channel blocking medication used for hypertension) or indomethacin (a non-steroidal anti-inflammatory drug) to try to buy precious hours for our extremely premature babies, both of which have their own risks. Atosiban (an oxytocin antagonist) is in the wings, but may have an increased risk of fetal death compared with some other medications, and less efficacy (according to a BJOG study). Consider what you want to ban carefully – if you get your wish, babies will suffer. I would give an awful lot to have a couple of vials of terbutaline in my back pocket when on the verge of delivering a 700 g (1.5 lb) micro-preemie baby to a mom whose contractions just won’t stop long enough for us to get steroids in.
To suggest this is a scientific blog is an insult to both journalists and scientists.
Sincerely,
Dr. C.M, MD FRCSC, OB/GYN
Canada

References:
J. Perinat. Med. 34 (2006) 359–366. Found at: http://www.porodnice.cz/upload/predcasny-porod/doporucene-postupy/International_PTL_Guidelines_Sept_2006.pdf
ACOG Guideline reference: http://www.guideline.gov/content.aspx?id=3993 (ACOG Practice Bulletin #43, cost applies for access)

As a point of clarity: the title of this blog post has already been revised to appropriately read, “FDA Warns Against Terbutaline for the Treatment of Preterm Labor.” Darline can address this further, but I would also like to point out that, as stated in the first sentence of her post, “US Food and Drug Administration issued warnings to the public stating that injectable Terbutaline, a potent bronchodilator indicated for the treatment of acute airway narrowing, should not be used for the long term prevention of preterm labor.” (my emphasis)

@CanDoc
I agree with what this Canadian doctor has written. These drugs have side effects, which are worsened when used in the long term. When you have a woman in prem labour at 24 weeks and you need to get her to a facility that will give her baby some chance of survival, the short term use of such substances is completley warranted. Those of us who work in the maternity field are acutely aware that stopping preterm labour for more than a few days is almost impossible. Tocolytics such as terbutaline are used to buy time whilst steroids kick in. I have always enjoyed this website but am disappointed with this piece, which seems to suggest that medical staff are ignoring side effects of substances deliberately. Very much like the misoprostol story.

Dr CM says strongly what I feel as well, which is that you (DTL) are speaking with great authority about something you seem to have very little experience with.

Physicians consider the risks and benefits of various courses of every decision. The risk of a shot of terbutaline is basically zero. There may be some risk with long term use of subcutaneous terb, but in hundreds of patients the only thing I ever saw was rare cases of reversible pulmonary edema in patients with multiple pregnancies. What I saw consistently, however, was a rapid cessation of contractions in patients on the drug.

The idea that every risk/benefit decision needs to be had in pow/wow with a patient is a little ridiculous. The vast majority of patients lack the experience and background to make informed decisions about these little issues. People focus on any tiny risk without really considering the magnitude of those risks, often denying themselves the benefit of beneficial interventions over irrational fears propagated by posts like this.

Does terb prevent preterm birth in the long term? No.

Does it stop contractions in the short term, making it a valuable tool in individual situations that demand short term tocolysis? Absolutely.

It is dangerous in short term use? No

I think it’s important to put the risk into perspective, since as it’s written this article gives the idea that terbutaline is very risky. According to your FDA link, there were 16 maternal deaths attributed to terbutaline between 1976 and 2009. As a rough estimate, during that time in the US there were approximately 4,000,000 births every year. Multiplying, we get 132,000,000 births over 33 years, so to be very conservative, I’ll say that we’re talking about 120,000,000 births.

According to the March of Dimes, about 3.5% of births occur before 34 weeks, so these are the births for which terbutaline or another tocolytic agent was most likely used to delay birth by a few days to get steroids on board. Multiplying again, we get 4,200,000 preterm or very preterm births over 33 years. Even assuming that only 1% of the women who had these preterm deliveries got terbutaline (42,000 women), 16/42,000 is 0.03%, or 3/10,000.

Put another way, the maternal death rate in the US has been ~8/100,000 for the past 30 years. That means that in this timeframe, there were around 9,600 maternal deaths, of which 16 (well less than 1%) were attributable to terbutaline. Add to this the fact that all of the deaths for which there is data, the terbutaline was administered either orally or at home via subcutaneous pump, the very routes that are now contra-indicated.

To me, the amazing thing is that so few deaths over such a long period of time were enough to modify guidelines to make women safer. Somebody somewhere is paying attention.

Dr. C.M.
First and foremost, I can’t speak to the practice and laws regarding the use of Terbutaline in Canada. The first three paragraphs of this post are from the US FDA report. I simply took what they said and restated it. Yes, the title was initially misprinted and we have made that correction. The last three paragraphs are my opinions and I stand by them for the following reasons.

I do believe that if the U.S. FDA has strong data regarding the efficacy and safety of a drug, they should take a stand. Issuing a black box warning 10-15 years after the drug has been used off label, without any sort of instruction or restriction, and with the potential side effects is not responsible. The US FDA is supposed to protect consumers in the United States. Their job is to make sure that the foods and drugs presented to the citizens of the United States are safe and that we know as much as possible about them and that they are being used as indicated. The way that Terbutaline has been used to date in this country, while effective in some cases, has been dangerous and deadly in others and women and babies, most of the time unknowingly, paid the price.

The US FDA has known for most of these years that Terbutaline was being used for the treatment of preterm labor. They could have issued a warning years ago. They could have given a limited indication, they could have issued guidelines because as you have said, ACOG and other prominent medical societies have been using the drug on a short term basis for years (International Guidelines have been available since 2006, your citation). Why not make it official? That would have eliminated this discussion. The problem is that when they examined studies they did not support Terbutaline’s efficacy. Consumer advocates have been pressing the FDA to put some stipulations on the use of Terbutaline, to take a stand, and it has finally come to pass (http://www.fda.gov/downloads/Drugs/DrugSafety/UCM243797.pdf). As one physician stated before you, without the evidence, it’s risky to use knowing the potential complications.

You state that Terbutaline is only used short term and has been recommended that way by the major medical societies. Perhaps the short term use is adhered to in Canada, but since the warning was issued, there has been much discussion here in the US among women who have been on the drug multiple times for multiple weeks, sometimes continuously. Women in the US shared that they were typically not told that Terbutaline was not FDA approved for the treatment of preterm labor nor were they advised of the potential side effects including death. (See Kendra’s Comment) Healthcare professionals in the US are supposed to obtain informed consent before performing any procedure or treatment. That does not mean giving a patient in distress a document full of legalese that she may not understand to sign, and accepting that signature as informed consent.

The reference that you provided, The International Guidelines, acknowledge that there is wide variability in treatment of preterm labor and try to offer a consensus to follow. They also state,

“There is considerable variation in the way that spontaneous preterm labor (SPTL) is diagnosed, managed and treated internationally.
The development of clinical guidelines requires an evidence-based approach to improve outcome and allow more efficient use of resources. With recent advances in our understanding of the etiology and mechanisms of SPTL and the availability of safer, more specific tocolytics, it was felt that guidelines should be developed to achieve, if possible, an European consensus in patient diagnosis, management and treatment.”

This is a great piece, one that the FDA can reference moving forward to further elucidate the best use of Terbutatline and other medications in obstetrical practice. That is what I am hoping for and asking for from the FDA, more clear cut guidelines to improve safety and efficacy. If they find after their research review that the risk of terbutaline outweighs the benefit, then yes, I hope that they will ban it and not hemm and haw with black box warnings. It is the US FDA’s responsibility to provide consumers with information so that they can make informed decisions and we in the US did not have such information to make such decisions.

You stated it yourself, there needs to be something available to give you time to treat very premature fetuses and neonates. Amen. In our country there is sometimes a lag to action until there is a stirring debate. This may be it and hey, if we get a good tocolytic out of it, then this discussion has been worth it. I know that there are many great researchers working on new drugs. I also know that my country is so woefully in debt, budgets are being cut and that funding for research is scarce. I am hoping that funding for research can keep pace with the need and not be stalled.

You don’t like the fact that I am questioning your years of training and practice but I don’t feel that years of training and practice give anyone, physician or not, the right to do whatever you want without question or accountability.

You want to save babies but let’s not do so at mama’s expense.

Many OB’s say, “Mother’s tell us to do anything to save their baby.” While this is true in many cases, it is not in all. When my husband and I were faced with a similar situation during my first pregnancy, he clearly stated that if it was a decision between saving my life and the life of our child’s, he would sign for treatments to save my life. He did not want to bring a helpless child into the world at the expense of a fully functioning adult. Many people would not agree with our decision, but it is one that we had the opportunity to talk through and make. Thankfully, my daughter and I are both fine.

Just so that you know, I do engage in research. No, I don’t have MD or Ph.D behind my name, but that does not invalidate what I or any of the other writers on this blog do. And you may not agree with what we write or the fact that we are bold enough to disagree with physicians. So be it. It doesn’t mean that our take on a particular subject is any less valid.

Dr. Fogelson,
I think I pretty much covered your remarks in my remarks to Dr. CM.

But I will add this, no matter what you think of a patient’s intelligence, you still owe them the right to know what you are recommending for their care and it behooves you, the physician, to make sure that information is presented in a way that the patient can understand so that they can decide if they want the treatment or not.

While working clinically in cardiology we had a patient with major coronary disease refuse the bypass. The doctors were incredulous but it was his decision and after a long discussion, it was noted that treatment was refused and the patient went on his way. Was it a wise decision, who knows, but it was his decision.

I stand by the statement that patients have a right to know everything about their treatments. Some patients will clearly state that they don’t want that much information and will give their doctors carte blanche. That is informed consent. Others, like me, a physician assistant and clinical researcher and my husband a physicist and engineer, want to know what you are proposing and we do have the mental capacity to understand.

Don’t judge your patients so harshly. Many of us do read multiple sources before making our decisions and we do have the capacity to weigh the information and do so.

la piranha: thank you for taking the time to look at this from a statistical perspective. I do want to make a correction, however: most recent estimates place the US maternal mortality rate at 24/100,000. Perhaps, because of the continued increase in maternal mortality in recent decades, the concern over anything which potentially puts a mother at risk is heightened. (Such as cardiac arrest as a side effect of a medication.) That is not to say we should stop worrying about fetuses who are at risk for pre-term birth and the complications that ensue. But perhaps this post can be a reminder for us to go back to the drawing board and think about other means of reducing the risk of preterm birth. (Watch for an up-coming post by Walker Karraa on the link between antenatal depression and pre-term birth). Rather than waiting to react to mounting, pre-term contractions, can we get back to focusing on preventative measures to decrease the incidence of pre-term labor in the first place?

As a big fan of this group, I find myself at odds with this article. I practised in the USA as an L&D nurse at a major Mid-Atlantic hospital with 7K+ births annually for many years, and often administered Terb for women in suspected pre-term labour. This was most important as a way to help stave of pre-term delivery, until steroids had a chance to promote surfactant development (2 doses IM over 24-48 hours). The side-effects were always explained to the woman so she would not be surprised at the tachycardia that followed – hard to not notice that! The next dose would be held if her heart rate was over 120bpm, until it came down, and only if she was still having significant contractions. It worked! And those women were perfectly happy to go through a day or two of this if it meant buying time for their babies lungs. Hand on heart, none of the women I cared for ever had a major clinical event following Terb under that protocol.

Now, I was NOT in favour of terb pumps and home monitoring. I often had the sense they were not worth the trouble the women went through, judging by the number of times they were re-admitted to the high risk perinatal unit for pre-term labour. As it looks to me, this FDA warning cuts out long-term use, not the usual 24-48 hour treatment we always did.

Kendra’s experience sounds like an example of poor practice at heart. There absolutely should have been a full history taken, including which meds and when. And if the doctor felt it was still worth giving Terb, that should have been fully discussed so she would have been fully informed. Kendra, if you very regularly take asthma meds, perhaps you don’t have tachycardia as a side effect anymore? And perhaps Terb wouldn’t have even worked for you? I’m not sure about that, but you deserved more of a discussion from the nurse and doctor.

Just to clarify this statement: “This was most important as a way to help stave of pre-term delivery, until steroids had a chance to promote surfactant development (2 doses IM over 24-48 hours).” The doses I wrote there refer to the steroids regimen. The terb, as I recall, was 0.25 mg subcu.

@Darline Turner-Lee

There is a clearly a need for informed consent with everything we do, but the magnitude of that information needs to be tailored to the magnitude of the intervention. We could sit around and talk for hours about the ins and outs of terbutaline and the tiny risks in long term use, but that is not practical.

A reasonable level of information in my opinion would be

“You have been feeling preterm contractions and we would like to give you a medication that will temporarily stop them. It will likely make your heart beat quickly for a period of time.”

If terbutaline is no longer available to suppress preterm contractions, I don’t know what women like me would do while pregnant. I’m guessing months of hospitalization, and preterm babies. I have an irritable uterus– I spent roughly eight weeks on terb and bedrest for each pregnancy, and went into labor within 24 hours of stopping terb for my second and third pregnancy. I understand that the research that has been done does not support the efficacy of terbutaline, but in my experience it works, and when I was not on a continuous dose of terb, I landed in the hospital on Magnesium Sulfate, a drug that truly terrifies me.

It’s very easy for someone who can carry a child to term without these drugs to celebrate their being made less available. To me, it’s celebrating children being born with lifelong disabilities, and as I look at my healthy, full-term children, I take that celebration very personally.

There is very little research on pregnancy complications, even bedrest hasn’t been proven effective. So the fact that terb hasn’t been proven to be effective isn’t actually all that damning.

@Nicholas Fogelson, MD
“A reasonable level of information in my opinion would be

“You have been feeling preterm contractions and we would like to give you a medication that will temporarily stop them. It will likely make your heart beat quickly for a period of time.””

I am glad you’re not my doctor, because that is not even CLOSE to enough information! To me, this sounds like the minimum amount of information that should be given to EVERY PATIENT (and not just the ones you personally decide to respct)

“You have been feeling preterm contractions and we would like to give you a medication. This medication was not developed for the purpose of stopping contractions. Some doctors feel that it stops contractions. The evidence however suggests that thei drug has no benefit. This drug does have significant risks. Many women have died while using this drug over an extended period of time because it affects the heart and can acause cardiac arrest. We do not intend to use it over the long term but only for long enough to allow us to use some other medications. These medications will give your baby a better chance of living despite being born much too early. You must decide whether you are willing to take on the risks of this drug in order to somewhat improve your child’s chance of surviving. It is a persoanl choice. Let me know when you are ready, what you would like to do.”

anything LESS than that is unethical.

@Nicholas Fogelson, MD
I was on terb for 13 weeks when I was pregnant with twins. We did invitro and luckily conceived the first transfer. I am so glad I was put on the terb. It stopped almost all my contractions and I never dilated!! I made it to 37 weeks and am so happy because I had to have a complete hysto. 11 weeks after they were born which I already knew I would. I know it is not indicated but I was on a terb pump and I was lucky. I am also a medic and knew the risks and to me it was worth it because it was a now or never pregnancy and I didn’t want to lose the babies. They are doing great and I am so happy for the terb pump. I understand the doctors take an oath but I also believe that the patient should have the right to choose. There are other medical procedures we don’t agree with but patients have the right to choose what they want and in this case they should be able to also. All drugs have side effects and serious allergic reactions. Some are more scary than others and they are approved by the FDA.

Is there a report that can be perused in relation to the maternal deaths caused by terbutaline? It would be interesting to read it. I wonder how many women had other risk factors?
@ Cassaundra You mention “many” women dying. Why would a health professional use this term?

I give patients narcotics all the time at appropriates doses. By your logic I should say “this drug given at high enough doses would make you stop breathing and you would die, but don’t worry we won’t use that much”

That’s not informed consent, it’s just scaring patients with irrelevant issues.

Terb used for short term to tocolysis is not associated with adverse outcomes. Even in long term use complications are very rare.

I took the day to watch all the comments back and forth. It’s been an interesting discussion.

Midwife UK, thank you for your clarification “This was most important as a way to help stave of pre-term delivery, until steroids had a chance to promote surfactant development (2 doses IM over 24-48 hours).” You gave what I saw in the International Guidelines as an acceptable short term dose. This is also the argument that Dr. CM used. However, if you read through the stories from former patients here in the US, you’ll see that continuous Terb was used and for longer than 24-48 hrs. Dr. CM and Dr. Fogelson chided me for wanting clearcut guidelines from the FDA and seeming to undermine a physician’s judgment. But what these stories on our thread shows is that while many clinicians such as yourself, Dr. Fogelson and Dr CM will follow recommended guidelines and recommended standards of practice, other physicians don’t. And while we have happy endings here, does that justify an “anything the clinician wants to try” approach because it works in some cases? I still agree with the FDA guidelines and the short term, in hospital injections.

Dr. Fogelson, I think that my comments were hard for you to take because you seem to practice responsibly. It’s no fun to be “accused” when you have “behaved as expected”. But as you can see from @BTDT and @R.Treb, these ladies were on Terb for a lot longer than the FDA’s or International Guidelines 24-48 hrs and both were on continuous infusion as opposed to the 25mg injections. Now both ladies state that they would have consented to the medication and felt that they had been adequately informed about the risks and benefits. But according to the FDA reports and the information they posted, longer use and continuous use are associated with increased adverse reactions and should not be used. I am one for playing by the rules. You can argue that for some women longer use or continuous use (as in the aforementioned cases) is necessary. But if these ladies had had different outcomes, how would this discussion thread be different?

Thank you @Leah and @Kendra for demonstrating that informed consent is not always obtained and many women want clear information before making their decisions (@Cassaundra).

It’s been a great discussion. Thank you all for your input.

I don’t think long term terb is necessary. It doesn’t seem to work.

My problem is not with your claim that terb is not useful in the long term, as this statement is evidence based in correct. My problem is with your choice of words.

@MW in Australia…

I agree about the “many women die” statement– I don’t think (or rather, hope or wish not) that a medical professional would use that kind of language.

However, Dr. Fogelson, a medical professional, just said, above, “Every OB who ever used it will say the same thing.” A completely indefensible and highly unscientific (arrogant?) sort of statement I would hope no scientist would ever use. And yet, there it is, in “black and white.”

Although it’s difficult to do so, risks and benefits need to be presented as objectively as possibly, while hopefully in relatively plain (yet not patronizing) language. I understand this is quite a difficult task! Which is why I’d like to see a LOT more training for HCPs towards that end. Informed consent is not being stressed as it deserves to be, and in some cases, it is dismissed or even openly mocked. That gets at the core of many problems with modern medical (and particularly maternity) care.

Well put, Dreamy, aka @MW in Australia.
I think that this thread has clearly shown that words are powerful and have to be chosen and used wisely. Thanks for your comment.

ACOG advocates using beta-mimetics to hold off labor for up to 72 hours to allow steroid administration and transfer to a hospital has adequate neonatal expertise. There exists medical evidence of reasonable quality to support this use with limited safety risk. To imply or state otherwise is simply not factual. FDA correctly deems this short term use as an acceptable risk because it is balanced with benefit. This short term use also is traditionally administered in the hospital. It would be a real injustice to eliminate this (short term) safe and efficacious use of terbutaline. Recall the FDA not long ago actually requested the drug sponsers to submit for this indication and no one stepped up. The safety of many drugs are dose and duration dependent; terbutaline is no different. The FDA acted correctly in this case by allowing the safe and effective off-label short term use of terbutaline; while warning of long term use which is a fairly common, dangerous and ineffective use.
Lastly, complications related to long term use frequently go unreported and may in fact be rare; but this use is of no proven benefit so why take the risk?

Hi Jim,
Thanks for your comment. If you take a read through this thread, you’ll see that there was quite a heated discussion about the use of Terbutaline. What eventually we all came away with is that while ACOG and the FDA advocate short term use based on clinical evidence, there are many OB’s who are not using Terbutaline in this fashion and not adequately informing patients of the risks posed with longterm use. As you will see from this thread, women themselves admitted to being on Terbutaline drips and on Terbutaline for weeks to months and not being aware of the risks. These situations are what are in question and what pose the greatest dangers for patients and physicians alike.

Thanks again for your comment

No doctors are not informing mothers of the maternal and fetal risks. Ive been given this medication starting in March and my last dose was a week ago and all my doctor and the nurses told me is. Dont worry you just mightget alittle jumpy. Not oh you can have a heart attck ir your baby might end up with a brain bleed

Hi Angela,
Thanks so much for sharing your story. As you can see from the posts, this has been a wild ride. Your story is very common amongst the women who posted here and amongst those to whom I have spoken about this issue.

While I can appreciate the benefits in short term usage of Terbutaline, this is not what I have seen or heard goes on in practice. Up until this FDA Warning/recommendation, ACOG issued “guidelines” but without any sort of specific enforcing authority, OB’s have done “whatever they felt was best in their medical opinion” and most times without fully informing their patients. Patients have the right to know that Terbutaline is being used off label (and quite possibly not in line even with the ACOG guidelines), what they expect in terms of results AND, most importantly, the potential risks and side effects.

If nothing else, the FDA warning/recommendations and this blog discussion have raised awareness amongst both practitioners and patients. My hope is that in the future if Terbutaline is brought up as a treatment option for preterm labor, everyone will enter the discussion well informed and that in the end, both OB AND patient are in agreement and satisfied with the course of treatment chosen-whether it includes Terbutaline or not.

I know i am waaaaay late on this article but for other women who may come across it i just want to share my experience:
I had cramping(contractions) from about 9 weeks till i delivered at 31 weeks after pprom. I was first given terb at 23 weeks. 5 shots, no dialation, contractions started immediately upon leaving the hospital again. I was sent back that afternoon, given terb every 3 hours for about 24 hours straight along withconstant iv fluids and some other med for contrax. Wasnt even told what it was, it was just injected in my iv. I was given a cerclage for cervical incompetence…..which is funny because i understood that cervical incompetence was characterized by dilation absent contractions…anyway. the cerclage seemed to cause even greater uterine irritability. Literally every week from 23 to 31 weeks i was back in l and d and every time i was given 3 to 5 shots of terb and eventually procardia and indomethacin combined. I was also given torodol in my iv and had to freak out on the nurse and make her call the dr to find out what the hell they were injecting into me!!! So in total i probably recieved between 30 and 40 shots of terb along with torodol, procardia, indo, and one or two drugs i never even knew the name of. At 29 weeks the peri ordered a terb pump for me. I flat out refused it. My ob said he understood my reasoning but recommended it anyway. The on call dr laugged in my face and refused to let me leave the hospital without it. I had to sign an ama form. The peri told me my insurance wouldnt cover it anyway but then marked me as a noncompliant patient!! The only person who was reasonable was a nurse who discussed the terb pump in depth with me and agreed that i shouldnt be a candidate for it. I had side effcts completely ignored and was treated like i was a monster. No one wanted to discuss risks or efficacy, it was their way or the highway. Not only did i have to deal with this from the hospital but now my refusal of the terb pump is even being used against me in a custody case…even after the fda warning. This is all just nuts to me and women need to start educating themselves and their drs if need be.

Just a note re: terbutaline not being approved for the treatment of preterm labor – none of the current “standard of care” medications currently used, i.e. magnesium sulfate, nifedipine, are FDA-approved. They are all being used “off-label”, meaning a use different than the one for which they received FDA approval.